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PMT Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation appropriate for the size of the device. Screws are intended for single use only.

The design features of the PMT Bone Screws are described below.

• Manufactured from Titanium Alloy .
• Available headed or headless ●
• Available in various diameters and lengths .

This document, K121713, is a 510(k) Premarket Notification for the PMT Bone Screws. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and performance data for the device itself.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not present in this type of submission. A 510(k) for a Class II device like a bone screw typically relies on performance testing (e.g., mechanical testing, biocompatibility) to show the new device is as safe and effective as existing legally marketed devices, rather than a clinical study evaluating diagnostic accuracy or a similar performance metric often seen with AI/diagnostic devices.

Here's an analysis based on the provided text, indicating where information is present and where it is not applicable to this type of submission:

1. A table of acceptance criteria and the reported device performance

• Not applicable in this 510(k) submission. The document does not describe specific acceptance criteria in terms of clinical performance or a table comparing such criteria to reported device performance. For bone screws, acceptance criteria typically relate to mechanical strength, fatigue resistance, and biocompatibility, which are usually demonstrated through bench testing and material specifications, not a clinical study with outcome metrics. The submission asserts substantial equivalence based on design features, material, and indications for use.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable. This submission does not describe a clinical study with a "test set" of patients or data in the way an AI/diagnostic device would. The "test set" concept does not apply to demonstrating substantial equivalence for a bone screw.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. There is no "ground truth" to be established by experts in the context of this 510(k) submission for a bone screw.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No adjudication method is described as there is no clinical study, test set, or expert review process mentioned for performance evaluation.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is a bone screw, not an AI or diagnostic tool. Therefore, an MRMC study and effects on human reader performance are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a bone screw, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable. As the device is a bone screw, "ground truth" in the diagnostic sense is not relevant. Its safety and effectiveness are established through compliance with recognized standards for mechanical properties and biocompatibility, and by demonstrating similar design and material to legally marketed predicate devices.

8. The sample size for the training set

• Not applicable. There is no "training set" for a bone screw device as described in this 510(k) submission.

9. How the ground truth for the training set was established

• Not applicable. Since there is no training set mentioned, this question is also not applicable.

Summary of Information from K121713 relevant to device acceptance:

The primary "acceptance criteria" for K121713 are implicitly met by demonstrating substantial equivalence to predicate devices. The study proving the device meets these criteria is the entire 510(k) submission itself, which articulates how the device is equivalent to already cleared devices.

• Device: PMT Bone Screws
• Intended Use: Bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.
• Approach to Acceptance: Substantial Equivalence to predicate devices: Wright Compression Screws (K082320) and ORTHOLOC Bone Screws (K112772).
• Evidence presented for Substantial Equivalence:
  • Design features (Manufactured from Titanium Alloy, available headed or headless, various diameters and lengths – common for bone screws).
  • Material (Titanium Alloy – common and well-characterized for orthopedic implants).
  • Indications for Use (identical to, or within the scope of, predicate devices).
  • "Materials information, and analysis data" (not detailed in the provided snippets, but typically would include biocompatibility data, mechanical testing results showing compliance with relevant standards like ASTM F543 for metallic bone screws, and possibly dimensional comparisons).

The FDA's decision to clear the device (SEP 27 2012) signifies their acceptance that the device is "substantially equivalent" to legally marketed predicate devices and thus is as safe and effective.

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